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Soo Park, MD
Soo Park, MD
Posted: Wednesday, November 27, 2024
According to Dirk Schadendorf, MD, of University Hospital Essen, Germany, and colleagues, the safety profiles of both the investigated dose levels of the BRAF inhibitor encorafenib plus the MEK inhibitor binimetinib and pembrolizumab were observed to be generally tolerable and comparable with those known for each agent alone in previously untreated patients with advanced BRAF V600–mutant melanoma. The safety lead-in results from the ongoing phase III STARBOARD study, which were published in the European Journal of Cancer, also identified 450 mg of encorafenib as the recommended phase III dose.
“BRAF inhibitors plus MEK inhibitors and immune checkpoint inhibitors are approved for BRAF V600–mutant advanced melanoma,” the investigators commented. “Combinations of BRAF and MEK inhibitors with immune checkpoint inhibitors may further improve outcomes and could offer additional treatment strategies.”
Patients with unresectable locally advanced or metastatic BRAF V600E/K–mutant cutaneous melanoma were treated with either 450 mg (n = 20) or 300 mg (n = 17) of encorafenib once daily plus 45 mg of binimetinib twice daily and 200 mg of pembrolizumab every 3 weeks in the first-line setting. Follow-up data were provided for a median of 19.4 months.
In the dose-limiting toxicity–evaluable analysis set (both arms, n = 17), such events were reported in one patient treated with 450 mg and two of those who received 300 mg. No treatment-related deaths were observed in either arm. The overall response rates with 450 mg and 300 mg of encorafenib were 65.0% and 47.1%, respectively.
“Results from the safety lead-in phase showed favorable and ongoing response… [and] did not demonstrate any new safety signals, including immune-related adverse events,” the investigators remarked. “The [efficacy and] safety of the triplet at the recommended phase III dose vs placebo plus pembrolizumab will be assessed further in the phase III part of the study.”
Disclosure: For full disclosures of the study authors, visit ejcancer.com.
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